Summary
Solicits stakeholder input on possible risk assessment, premarket evaluation, postmarket monitoring and other approaches for generative AI-enabled medical devices. Discusses competency-based evaluation, foundation-model information and agentic systems. The paper expressly represents neither draft nor final guidance and implements no policy changes.
Healthcare Implications
Device developers and healthcare implementers can use the paper to understand questions FDA is exploring about GenAI evidence and lifecycle oversight. It creates no new approval pathway, evidence requirement or exemption; comments were requested by October 19, 2026.